NCT00358761

Investigation of Southern Tick-Associated Rash Illness (STARI)

Terminated Last updated 17 December 2019

What this trial tests

trial in Southern Tick-Associated Rash Illness in 3 participants. Terminated before completion.

Timeline

20 July 2006

11 December 2012

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	3
Start date	20 July 2006
Estimated completion	11 December 2012
Sites	1 location across United States

Conditions studied

• Southern Tick-Associated Rash Illness — all drugs for Southern Tick-Associated Rash Illness →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

14 and older, any sex, with Southern Tick-Associated Rash Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate blood and tissue samples for a condition called Southern Tick-Associated Rash Illness (STARI). This is a skin rash resembling erythema migrans, the rash found in people infected with Lyme disease. In the south and southeastern United States, STARI is associated with the bite of the lone star tick. Researchers seek a better understanding of the cause of STARI. Through researchers' knowledge, diagnostic tests could be developed. NIH is conducting this study along with the Centers for Disease Control and Prevention (CDC).

Patients ages 14 years and older who have recently been diagnosed with possible STARI, who have not taken antibiotics for it longer than 1 day, and whose skin does not form large scars may be eligible for this study. About 20 participants will be enrolled over a 5-year period. Patients will visit the NIH Clinical Center for two or three visits. The first visit may last 2 hours. Photographs will be taken of the rash, and a blood sample of about 1-1/2 tablespoons will be collected for tests. Patients will undergo a punch biopsy of three small pieces of skin, from the rash. The area of the skin will be cleaned, and patients will receive a local anesthetic at the biopsy site. A sharp instrument will remove a round plug of skin, about the size of half a pencil eraser. Patients may feel a pushing sensation, but there should not be pain. The site usually heals without sutures, though the doctors may close it with special adhesive bandages or one or two sutures. Patients will receive instructions about how to take care of the biopsy site. If sutures are used, patients will return in 7 to 10 days to have them removed-or a patient's own doctor may remove the sutures. Patients will return to NIH at 4 to 6 weeks following their first visit. At that time, they will answer questions about how they are doing and donate about 2 tablespoons of blood. Blood and skin samples will be used for research at NIH and CDC.

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Publications & conference data

No peer-reviewed publications indexed yet for this trial.